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Cancer Vaccine

Vaccine + Poly-ICLC for Pediatric Brain Cancer

Phase 1
Waitlist Available
Led By Alberto Broniscer, MD
Research Sponsored by Ian F. Pollack, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stratum A: Newly diagnosed diffuse intrinsic pontine gliomas OR any biopsy proven high-grade glioma* involving the brainstem. Patients may not have received chemotherapy during or after radiation. (Note: Stratum A is closed to accrual.)
Stratum D: Non-brainstem high-grade gliomas* that have recurred following treatment. (Note: Stratum D is closed to accrual.)
Must not have
Interferon (e.g. Intron-A®)
Any investigational therapeutic medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether a vaccine is safe and generates an immune response. If so, a larger study will be done to see if the vaccine is effective.

Who is the study for?
This trial is for children and young adults (1-21 years old) with specific types of brain tumors called pediatric gliomas. Participants must have stable health, not be pregnant, agree to birth control use, and meet certain criteria based on their tumor type and previous treatments. They should also have a good performance status and life expectancy of at least 8 weeks.
What is being tested?
The study tests the safety and immune response to a vaccine made from glioma antigen peptides combined with Poly-ICLC in patients with pediatric gliomas. The goal is to determine if this approach warrants further investigation in larger clinical efficacy trials.
What are the potential side effects?
Potential side effects may include reactions at the injection site, flu-like symptoms such as fever or chills, fatigue, allergic responses, or other immune-related effects due to stimulation of the body's defense mechanisms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a new diagnosis of a specific brainstem tumor and haven't had chemotherapy during or after radiation.
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My high-grade glioma has come back after treatment.
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I have a new high-grade glioma and haven't had chemotherapy with my radiation.
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I have been on a low dose or no corticosteroids for at least a week.
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My diagnosis is GBM, AA, or gliosarcoma without any oligodendroglioma component.
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I am between 12 months and 22 years old.
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My kidney function is good based on tests.
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My blood and liver tests are within the required ranges.
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I have received radiation therapy to my brain and spine.
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I do not have any infections in my body.
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I am mostly independent and active.
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My immune system marker, HLA-A2, is positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking or have taken Interferon.
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I am not currently taking any experimental drugs.
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I do not have, nor have I ever had, an autoimmune disorder.
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My cancer has spread to my brain or spinal cord.
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I am currently taking or have taken Proleukin.
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I am taking medications to help with blood cell counts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monitoring will continue as long as subject remains on study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and monitoring will continue as long as subject remains on study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety: Tolerability during the first two vaccine courses as defined in the protocol.
Secondary study objectives
Glioma-associated antigen-specific T-cell response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: HLA Restricted glioma antigen peptides plus Poly ICLCExperimental Treatment2 Interventions
All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poly-ICLC
2016
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Ian F. Pollack, M.D.Lead Sponsor
4 Previous Clinical Trials
72 Total Patients Enrolled
James FelkerLead Sponsor
2 Previous Clinical Trials
49 Total Patients Enrolled
Ellie Kavalieros FundUNKNOWN

Media Library

Pediatric Glioma Clinical Trial 2023: HLA-A2 restricted glioma antigen peptides vaccine Highlights & Side Effects. Trial Name: NCT01130077 — Phase 1
~0 spots leftby Dec 2024
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